FDA.reportPublic FDA data

MAUDE MDR 163277

MDR report key
163277
Report number
163277
Event key
0
Event type
3
Date of event
1998-04-09
Date received
1998-04-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WOLF SICKLE KNIFESICKLE KNIFE- SHARPRICHARD WOLF MED INSTRUMENTS CORP.KTGWOLF 8211.90**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11998-04-1701. H; 2. R

Event Narratives#

D

Patient 1

A 39 YEAR OLD MALE IN OUTPATIENT SURGICAL CTR MAXILLARY AND LEFT SPHENOID SINUS SURGERY, SEPTOPLASTY AND NASAL TIP PLASTY. WHILE MD USING THE SICKLE KNIFE IN THE NOSE, SNAP HEARD, WHEN INSTRUMENT REMOVED FROM THE NOSE, THE MD & SCRUB NOTICED A PORTION OF THE BLADE MISSING FROM THE HANDLE. SURGEON UNABLE TO LOCATE THE BLADE VISUALLY AND X-RAY DONE IMMEDIATELY. LOCATED TIP AND MD REMOVED PIECE OF BLADE. AT THAT TIME A CEREBROSPINAL FLUID LEAK WAS NOTED FROM THE AREA OF THE CRIBRI-FORM PLATE. MD ATTEMPTED TO SEAL/PATCH LEAK BUT LEAK CONTINUED AND PT ADMITTED TO ANOTHER FACILITY FOR LUMBAR DRAIN PLACEMENT FOR DIVERSION AND OBSERVATION.